Health Effects of Salmon Fishmeal in Humans (FishMeal)

University of Oslo

Status: Completed

Conditions: Impaired Glucose Tolerance

Treatments: Dietary Supplement: Salmon fishmeal; Dietary Supplement: Microcrystalline cellulose

Study type: Interventional

Funder types: Other

Identifiers

NCT03764423

901420

Details and patient eligibility

About

Diabetes contributes significantly to the burden of disease in Norway and cardiovascular disease is the main cause of mortality.

Both lean and fatty fish are shown to have beneficial health effects. In addition to omega-3 fatty acids, fish contain potential health-promoting components such as taurine, vitamin D, vitamin B12, iodine, selenium and more unspecified components such as bioactive peptides. With the expected growth in the aquaculture sector, more protein-rich by-products will become available.

The overall aim of this project is to investigate the health beneficial effects of fish protein in the form of salmon fishmeal in a human intervention study with regard to metabolic risk markers.

We will include subjects with impaired glucose tolerance to a randomized controlled parallel study. The subjects will receive capsules with fishmeal or placebo.

Enrollment: 88 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Fasting plasma glucose ≥ 5.6 mmol/l or
• Plasma glucose ≥ 6.5 mmol/l 2h after an OGTT or
• HbA1c ≥ 5.8 %

Exclusion criteria

• Diabetes (defined as p-glucose ≥ 7.0 mmol/l p-glucose ≥11,1 mmol/l 2h after OGTT or HbA1c ≥ 6.5 %)
• High fish intake (> 450 gram/week) or fish allergy
• Age-related elevated blood pressure (≥ 70 år: ≥ 180/110 mmHg, > 40-70: ≥ 170/100 mmHg and ≤ 40 år: ≥ 160/100 mmHg)
• Use of prescription medicines related to diabetes, inflammation, systemic use of corticosteroids.
• Non-stable use of lipid lowering drugs, thyroxine, blood pressure lowering drugs, drugs affecting appetite, dietary supplements (including n-3)
• High intake of protein supplements powder
• Pregnancy
• Planning pregnancy or changes in body weight

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

88 participants in 2 patient groups, including a placebo group

Salmon fishmeal

Experimental group

Description:

7,5 g fishmeal and 7,5 g microcrytalline cellulose per day in capsules by mounth for 8 weeks

Treatment:

Dietary Supplement: Salmon fishmeal

Microcrystalline cellulose

Placebo Comparator group

Description:

7,5 g microcrystalline cellulose per day in capsules by mounth for 8 weeks

Treatment:

Dietary Supplement: Microcrystalline cellulose